Alert April 21, 2020

Qualifying for Immunity Under the U.S. PREP Act During COVID-19

As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. § 247d-6d. This Declaration activated immunity from personal injury, property damage, and other types of claims for companies and certain professionals who manufacture, distribute, or use “covered countermeasures”— certain drugs and devices, or components thereof, that may be used to treat COVID-19 patients or combat the COVID-19 pandemic.[1] The PREP Act provides broad immunity from liability, but applies only to products and persons that qualify for the immunity under the PREP Act and the limits established in the Secretary’s Declaration.

1. The PREP Act

The purpose of the PREP Act is to allow companies and individuals to quickly respond to a public health emergency with products without subjecting those individuals to liability for damage caused by the products. The Act confers immunity to certain “covered persons” from liability for losses resulting from use of a “covered countermeasure” to combat a disease or other threat to health that constitutes a public health emergency.[2] Once triggered, the PREP Act provides broad protection for covered persons from liability for “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure,” including death, physical, mental, or emotional injury, and property damage or loss.[3] To activate the protections afforded by the PREP Act, the Secretary must issue a declaration after making a determination of a public health emergency, identifying the covered countermeasures to which the immunity applies, and setting certain conditions for the immunity triggered by the declaration.[4] The Secretary’s March 10, 2020 Declaration, which was published in the Federal Register on March 17, 2020, and is effective retroactively as of February 4, 2020, states that “the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease, COVID-19, constitutes a public health emergency,” and activates the PREP Act’s immunity provisions.[5]

2. Covered Persons

PREP Act immunity is limited to covered persons. These include persons or entities that are manufacturers, distributors, and program planners of covered countermeasures.[6] The term “manufacturers” includes a manufacturer’s contractors, subcontractors, affiliates, parents, subsidiaries, successors, assigns and suppliers or licensors of certain things and services used in the development or manufacturing of a covered countermeasure.[7] “Distributors” are those parties engaged in the distribution of drugs, biologics, or devices, including manufacturers, repackers, carriers, own-label and private-label distributors, jobbers, brokers, warehouses, independent wholesale drug traders, and retail pharmacies.[8] The term “program planners” refers to a State or local government, a person employed by the State or local government, or other persons “who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product.”[9]

“Qualified persons” are also covered persons, and they are defined as licensed health professionals or other individuals authorized under State law to prescribe, administer, or dispense covered countermeasures.[10] The Secretary’s March 10, 2020 Declaration establishes that, in addition to the categories of “qualified persons” identified in the PREP Act, for purposes of the coronavirus public health emergency, covered persons also includes “[a]ny person authorized … to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures” in “accordance with the public health and medical emergency response”[11] of a local, state, or federal agency with “legal responsibility and authority for responding to an incident.”[12]

3. Covered Countermeasures

Under the PREP Act, “covered countermeasures” include:

  1. Qualified pandemic or epidemic products;
  2. Security countermeasures as defined in 42 U.S.C. § 247d-6b(c)(1)(B);
  3. Drugs, biological products, and devices that are authorized for emergency use by FDA;[13] and
  4. Certain respiratory protective devices.[14]

    “Qualified pandemic or epidemic products” are drugs, biological products, or devices that are “manufactured, used, designed, developed, modified, licensed, or procured … to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic” or address a pandemic or epidemic in several other specified ways, and are either (1) approved, licensed, or cleared by FDA, (2) authorized by FDA for investigational use under 21 U.S.C. § 355(i) or 360j(g) (i.e. investigational new drugs and devices), or (3) authorized for emergency use by the Secretary.[15]

    “Security countermeasures” include drugs, biological products, or devices that “the Secretary determines to be a priority … to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent” and “necessary countermeasure[s]” and are approved, licensed, or cleared by FDA (or for which the Secretary determines there is sufficient clinical experience or research data to “support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years”). Security countermeasures also include drugs, biological products, or devices authorized for emergency use by the Secretary.[16]

    Certain respiratory protective devices were recently added to covered countermeasures specifically in response to the coronavirus pandemic. As part of the Families First Coronavirus Response Act,[17] and the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”),[18] the definition of covered countermeasures in the PREP Act was amended to include respiratory protective devices that have been “approved by the National Institute for Occupational Safety and Health” under 42 C.F.R. Part 84, and that “the Secretary determines to be a priority for use during a public health emergency” declared under the PREP Act.

    In the Secretary’s April 10, 2020 Amendment to the March 10, 2020 Declaration, the Secretary declared that, for purposes of the COVID-19 epidemic, covered countermeasures, which must fall into one of the four categories identified in the statute, are “any antiviral, any other drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 … or any device used in the administration of any such product, and all components and constituent materials of any such product.”[19] The Secretary also declared that “use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency”, and that covered countermeasures include such respiratory protective devices.[20]

4. Emergency Use Authorization

Because of the PREP Act’s definition of covered countermeasures, many countermeasures may require emergency use authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) to qualify for PREP Act immunity. The criteria for such authorization are set forth in the Federal Food, Drug, and Cosmetic Act.[21] These criteria include: (1) the agent that the product is meant to counteract “can cause a serious or life-threatening disease or condition,” (2) “based on the totality of the scientific evidence available,” it is reasonable to believe that the product may be effective for the specified use (a lower standard than the “effectiveness” standard FDA uses for product approvals), (3) a risk-benefit analysis favors emergency use of the product, and (4) “there is no adequate, approved, and available alternative” to the product.[22]

Since the March 10, 2020 Declaration, FDA has already issued emergency use authorizations for a number of products intended for use in response to the coronavirus pandemic,[23] including diagnostic test kits,[24] ventilators and ventilator accessories,[25] and certain personal protective equipment such as respirators.[26]  On April 9, 2020, FDA issued a new EUA for “the use of face shields by HCP as PPE in health care settings.”[27]

5. Limits on Immunity

Although PREP Act immunity is broad, it is not unlimited.

First, the Act does not confer immunity in cases of willful misconduct resulting in death or serious physical injury.[28] However, even in cases of alleged willful misconduct, the Act places limits on the appropriate forum and specifies additional pleading requirements.

Second, the immunity does not apply to all methods of distribution. The Secretary’s Declaration specifies that immunity is only afforded to “covered persons” for “recommended activities” involving “covered countermeasures” related to “[p]resent or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements” or “activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a Declaration of an emergency.”[29]  The “Authority Having Jurisdiction” is defined as “the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.”[30] 

Third, the immunity is also cabined by the effective dates in the Secretary’s Declaration. Currently, for covered countermeasures distributed via federal channels, the immunity is effective from February 4, 2020 until October 1, 2024. For covered countermeasures distributed via non-federal channels, the immunity extends from February 4, 2020 until “the earlier of October 1, 2024 or the end of the emergency Declaration by the relevant agency.”[31] In both cases, there is a 12-month window of additional immunity at the conclusion of the effective date of the Declaration for manufacturers “to arrange for disposition of the Covered Countermeasures.”[32] The immunity conferred upon respiratory protective devices pursuant to the March 27, 2020 amendment to the PREP Act is effective starting on March 27, 2020.[33]

If you have questions or seek advice concerning the PREP Act, please contact Stephanie Philbin in Goodwin’s Tech/Life Sciences group or Sarah Frederick or Richard Oetheimer in the Product Liability and Counseling group.

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[1] 42 U.S.C. § 247d-6d(b).

[2] 42 U.S.C. § 247d–6d(a)(1) and (b)(1).

[3] 42 U.S.C. § 247d–6d(a)(1)-(2).

[4] 42 U.S.C. § 247d–6d(b)(1)-(5).

[5] See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15189 (Mar. 17, 2020) (“March 10, 2020 Declaration”). The Secretary’s Declaration was amended on April 10, 2020 to supplement the Secretary’s findings with respect to certain respiratory protective devices to address new requirements that were added to the statute. See Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 85 Fed. Reg. 21012 (Apr. 15, 2020), (“April 10, 2020 Amendment”).

[6] 42 U.S.C. § 247d–6d(i)(2).

[7] 42 U.S.C. § 247d–6d(i)(4),

[8] 42 U.S.C. § 247d–6d(i)(3).

[9] 42 U.S.C. § 247d–6d(i)(6).

[10] 42 U.S.C. § 247d–6d(i)(2),(8),

[11] March 10, 2020 Declaration at 15201,

[12] Id. at 15202.

[13] “Drugs,” “biological products,” and “devices” are as defined in 21 U.S.C. § 321(g)(1), 42 U.S.C. § 262(i), and 21 U.S.C. § 321(h), respectively.

[14] 42 U.S.C. § 247d–6d(i)(1).

[15] 42 U.S.C. § 247d-6d(i)(7).

[16] 42 U.S.C. § 247d-6d(i)(9) and 42 U.S.C. §247d-6b(c)(1)(B).

[17] Pub. L. No. 116-127 § 6005 (2020).

[18] Pub. L. No. 116-136 § 3103 (2020).

[19] April 10, 2020 Amendment at 21014.

[20] April 10, 2020 Amendment at 21013-21014.

[21] See 21 U.S.C. § 360bbb–3.

[22] 21 U.S.C. § 360bbb–3(c).

[23] See Food & Drug Admin, Emergency Use Authorizations (last visited April 15, 2020)

[24] See, e.g., Food & Drug Admin., Letter from Denise M. Hinton, Chief Scientist to Jill Taylor, Director, New York State Department of Public Health (Mar. 10, 2020) (authorizing emergency use of the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel); Letter from Denise M. Hinton, Chief Scientist to Rita Hoady, Senior Manager, Regulatory Affairs, Roche Molecular Systems, Inc. (Mar. 12, 2020) (authorizing emergency use of the cobas SARS-CoV-2 diagnostic kit). See also, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (listing EUAs for coronavirus in vitro diagnostic products).

[25] Food & Drug Admin., Letter from Denise M. Hinton, Chief Scientist to Manufacturers and Other Stakeholders (Mar. 24, 2020) (providing EUA for certain ventilators and ventilator accessories).

[26] Food & Drug Admin., Letter from Denise M. Hinton, Chief Scientist to Robert R. Redfield, Director, Centers for Disease Control & Prevention (Mar. 28, 2020) (EUA for NIOSH-approved respirators); Food & Drug Admin., Letter from Denise M. Hinton, Chief Scientist to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, et al. (Mar. 28, 2020), (EUA for non-NIOSH-approved respirators).  

[27] Food & Drug Admin., Letter from Denise M. Hinton, Chief Scientist to Manufacturers of Face Shields, Health Care Personnel; Hospital Purchasing Departments and Distributors; and Any Other Stakeholders (as revised and amended, Apr. 13, 2020)    

[28] 42 U.S.C. § 247d–6d(d).

[29] March 10, 2020 Declaration at 15202.

[30] Id.

[31] March 10, 2020 Declaration at 15202; April 10, 2020 Amendment at 21014.

[32] March 10, 2020 Declaration at 15202.

[33] April 10, 2020 Declaration at 21014.